On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
2 other identifiers
observational
3,789
1 country
4
Brief Summary
Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2020
CompletedStudy Start
First participant enrolled
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2022
CompletedApril 12, 2023
April 1, 2023
1.1 years
June 7, 2020
April 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee impact summary
Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Secondary Outcomes (7)
Fast-paced walking ability
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Chair-stand ability
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Self-reported function
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported pain
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported quality of life
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
- +2 more secondary outcomes
Other Outcomes (11)
Patient satisfaction
Primary follow-up point: Completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Continuation of exercise
Follow-up point: 12 months
Self-reported activity levels
Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
- +8 more other outcomes
Study Arms (2)
On-line exercise and education
Exercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists.
On-site exercise and education
Exercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists.
Interventions
Exercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session. Education: Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
Exercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark. Education: Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
Eligibility Criteria
Patients included into this study are adults, reporting knee OA symptoms as their main source of pain. Both study groups (on-line and on-site exercise and education) are comprised of patients with symptomatically verified (all) and radiographically verified (most) knee OA. On-line exercise and education: Patients referred for assessment in secondary care due to knee OA symptoms. On-site exercise and education: Patients with knee OA symptoms referred to a physiotherapist either by their general practitioner, by an orthopedic surgeon, or by self-referral.
You may qualify if:
- Knee OA symptoms resulting in contact with the health care system
You may not qualify if:
- Another reason than OA for the problems; includes tumour or inflammatory joint disease
- Other symptoms that are more pronounced than the OA symptoms; i.e. chronic, generalised pain or fibromyalgia.
- In addition, for the on-line study group:
- Previous participation in similar exercise and education programs (i.e. the on-site version)
- Lack of necessary equipment or skills to administer on-line participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Slagelse Hospitallead
- Region Zealandcollaborator
Study Sites (4)
Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals
Næstved, Region Sjælland, 4700, Denmark
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
Næstved, Region Sjælland, 4700, Denmark
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
Slagelse, Region Sjælland, 4200, Denmark
University of Southern Denmark
Odense, Region Southern Denmark, 5230, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pætur M Holm, PhD
Department of Physiotherapy and Occupational Therapy
- STUDY CHAIR
Søren T Skou, Professor
Department of Physiotherapy and occupational Therapy
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist, PhD, Postdoc.
Study Record Dates
First Submitted
June 7, 2020
First Posted
June 18, 2020
Study Start
June 12, 2020
Primary Completion
July 10, 2021
Study Completion
June 14, 2022
Last Updated
April 12, 2023
Record last verified: 2023-04